Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine: Second interim analysis of data from a phase III, multi- institutional trial

Marc K. Wallack, Muthukumaran Sivanandham, Kristen Ditaranto, Palma Shaw, Charles M. Balch, Marshall M. Urist, Kirby I. Bland, Douglas Murray, William A. Robinson, Lawrence Flaherty, Jon M. Richards, Les Rosen, Alfred A. Bartolucci

Research output: Contribution to journalArticle

Abstract

Objective: The efficacy of vaccinia melanoma oncolysate (VMO) vaccine to increase overall survival and disease-free survival of patients with surgically resected International Union Against Cancer (UICC) stage II melanoma was studied in a phase III, randomized, multi-institutional trial. Summary Background Data: Phase I and II trials with VMO showed minimal toxicity and clinical efficacy in patients with melanoma. In a recently completed phase III VMO trial, the first interim analysis performed in April 1994 showed an increasing trend in the survival of patients treated with VMO. The second interim analysis was performed in April 1995. Methods: Patients with surgically resected stage II (UICC) melanoma were treated with VMO (N = 104) or placebo vaccinia vaccine virus (V) (N = 113) once a week for 13 weeks and then once every 2 weeks for a total of 12 months. Patients' clinical data were collected as of May 1995 and analyzed for survival. Results: In this second interim analysis, the mean follow-up time is 42.28 months. No survival difference was observed between VMO and V treatments. However, in a retrospective subset analysis, a subset of males between the ages of 44 and 57 years and having one to five positive nodes (at 2-, 3-, and 5-year intervals, 13.6%, 15.9%, and 20.3% difference in survival in favor of VMO [N = 20] when compared to V [N = 18] [p = 0.037]) and another subset of patients with clinical stage I (at 3- and 5-year intervals, 30% and 7% difference in survival in favor of VMO [N = 20] when compared to V [N = 23], [p = 0.05]) showed significant survival advantage with VMO. Conclusions: Although VMO vaccine therapy in surgical adjuvant setting did not produce a significant survival benefit to all patients with melanoma, patients from the above two subsets had significant survival benefit.

Original languageEnglish (US)
Pages (from-to)198-206
Number of pages9
JournalAnnals of Surgery
Volume226
Issue number2
DOIs
StatePublished - 1997
Externally publishedYes

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Vaccinia
Melanoma
Vaccines
Survival
Active Immunotherapy
Vaccinia virus
Disease-Free Survival

ASJC Scopus subject areas

  • Surgery

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Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine : Second interim analysis of data from a phase III, multi- institutional trial. / Wallack, Marc K.; Sivanandham, Muthukumaran; Ditaranto, Kristen; Shaw, Palma; Balch, Charles M.; Urist, Marshall M.; Bland, Kirby I.; Murray, Douglas; Robinson, William A.; Flaherty, Lawrence; Richards, Jon M.; Rosen, Les; Bartolucci, Alfred A.

In: Annals of Surgery, Vol. 226, No. 2, 1997, p. 198-206.

Research output: Contribution to journalArticle

Wallack, MK, Sivanandham, M, Ditaranto, K, Shaw, P, Balch, CM, Urist, MM, Bland, KI, Murray, D, Robinson, WA, Flaherty, L, Richards, JM, Rosen, L & Bartolucci, AA 1997, 'Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine: Second interim analysis of data from a phase III, multi- institutional trial', Annals of Surgery, vol. 226, no. 2, pp. 198-206. https://doi.org/10.1097/00000658-199708000-00012
Wallack, Marc K. ; Sivanandham, Muthukumaran ; Ditaranto, Kristen ; Shaw, Palma ; Balch, Charles M. ; Urist, Marshall M. ; Bland, Kirby I. ; Murray, Douglas ; Robinson, William A. ; Flaherty, Lawrence ; Richards, Jon M. ; Rosen, Les ; Bartolucci, Alfred A. / Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine : Second interim analysis of data from a phase III, multi- institutional trial. In: Annals of Surgery. 1997 ; Vol. 226, No. 2. pp. 198-206.
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title = "Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine: Second interim analysis of data from a phase III, multi- institutional trial",
abstract = "Objective: The efficacy of vaccinia melanoma oncolysate (VMO) vaccine to increase overall survival and disease-free survival of patients with surgically resected International Union Against Cancer (UICC) stage II melanoma was studied in a phase III, randomized, multi-institutional trial. Summary Background Data: Phase I and II trials with VMO showed minimal toxicity and clinical efficacy in patients with melanoma. In a recently completed phase III VMO trial, the first interim analysis performed in April 1994 showed an increasing trend in the survival of patients treated with VMO. The second interim analysis was performed in April 1995. Methods: Patients with surgically resected stage II (UICC) melanoma were treated with VMO (N = 104) or placebo vaccinia vaccine virus (V) (N = 113) once a week for 13 weeks and then once every 2 weeks for a total of 12 months. Patients' clinical data were collected as of May 1995 and analyzed for survival. Results: In this second interim analysis, the mean follow-up time is 42.28 months. No survival difference was observed between VMO and V treatments. However, in a retrospective subset analysis, a subset of males between the ages of 44 and 57 years and having one to five positive nodes (at 2-, 3-, and 5-year intervals, 13.6{\%}, 15.9{\%}, and 20.3{\%} difference in survival in favor of VMO [N = 20] when compared to V [N = 18] [p = 0.037]) and another subset of patients with clinical stage I (at 3- and 5-year intervals, 30{\%} and 7{\%} difference in survival in favor of VMO [N = 20] when compared to V [N = 23], [p = 0.05]) showed significant survival advantage with VMO. Conclusions: Although VMO vaccine therapy in surgical adjuvant setting did not produce a significant survival benefit to all patients with melanoma, patients from the above two subsets had significant survival benefit.",
author = "Wallack, {Marc K.} and Muthukumaran Sivanandham and Kristen Ditaranto and Palma Shaw and Balch, {Charles M.} and Urist, {Marshall M.} and Bland, {Kirby I.} and Douglas Murray and Robinson, {William A.} and Lawrence Flaherty and Richards, {Jon M.} and Les Rosen and Bartolucci, {Alfred A.}",
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T1 - Increased survival of patients treated with a vaccinia melanoma oncolysate vaccine

T2 - Second interim analysis of data from a phase III, multi- institutional trial

AU - Wallack, Marc K.

AU - Sivanandham, Muthukumaran

AU - Ditaranto, Kristen

AU - Shaw, Palma

AU - Balch, Charles M.

AU - Urist, Marshall M.

AU - Bland, Kirby I.

AU - Murray, Douglas

AU - Robinson, William A.

AU - Flaherty, Lawrence

AU - Richards, Jon M.

AU - Rosen, Les

AU - Bartolucci, Alfred A.

PY - 1997

Y1 - 1997

N2 - Objective: The efficacy of vaccinia melanoma oncolysate (VMO) vaccine to increase overall survival and disease-free survival of patients with surgically resected International Union Against Cancer (UICC) stage II melanoma was studied in a phase III, randomized, multi-institutional trial. Summary Background Data: Phase I and II trials with VMO showed minimal toxicity and clinical efficacy in patients with melanoma. In a recently completed phase III VMO trial, the first interim analysis performed in April 1994 showed an increasing trend in the survival of patients treated with VMO. The second interim analysis was performed in April 1995. Methods: Patients with surgically resected stage II (UICC) melanoma were treated with VMO (N = 104) or placebo vaccinia vaccine virus (V) (N = 113) once a week for 13 weeks and then once every 2 weeks for a total of 12 months. Patients' clinical data were collected as of May 1995 and analyzed for survival. Results: In this second interim analysis, the mean follow-up time is 42.28 months. No survival difference was observed between VMO and V treatments. However, in a retrospective subset analysis, a subset of males between the ages of 44 and 57 years and having one to five positive nodes (at 2-, 3-, and 5-year intervals, 13.6%, 15.9%, and 20.3% difference in survival in favor of VMO [N = 20] when compared to V [N = 18] [p = 0.037]) and another subset of patients with clinical stage I (at 3- and 5-year intervals, 30% and 7% difference in survival in favor of VMO [N = 20] when compared to V [N = 23], [p = 0.05]) showed significant survival advantage with VMO. Conclusions: Although VMO vaccine therapy in surgical adjuvant setting did not produce a significant survival benefit to all patients with melanoma, patients from the above two subsets had significant survival benefit.

AB - Objective: The efficacy of vaccinia melanoma oncolysate (VMO) vaccine to increase overall survival and disease-free survival of patients with surgically resected International Union Against Cancer (UICC) stage II melanoma was studied in a phase III, randomized, multi-institutional trial. Summary Background Data: Phase I and II trials with VMO showed minimal toxicity and clinical efficacy in patients with melanoma. In a recently completed phase III VMO trial, the first interim analysis performed in April 1994 showed an increasing trend in the survival of patients treated with VMO. The second interim analysis was performed in April 1995. Methods: Patients with surgically resected stage II (UICC) melanoma were treated with VMO (N = 104) or placebo vaccinia vaccine virus (V) (N = 113) once a week for 13 weeks and then once every 2 weeks for a total of 12 months. Patients' clinical data were collected as of May 1995 and analyzed for survival. Results: In this second interim analysis, the mean follow-up time is 42.28 months. No survival difference was observed between VMO and V treatments. However, in a retrospective subset analysis, a subset of males between the ages of 44 and 57 years and having one to five positive nodes (at 2-, 3-, and 5-year intervals, 13.6%, 15.9%, and 20.3% difference in survival in favor of VMO [N = 20] when compared to V [N = 18] [p = 0.037]) and another subset of patients with clinical stage I (at 3- and 5-year intervals, 30% and 7% difference in survival in favor of VMO [N = 20] when compared to V [N = 23], [p = 0.05]) showed significant survival advantage with VMO. Conclusions: Although VMO vaccine therapy in surgical adjuvant setting did not produce a significant survival benefit to all patients with melanoma, patients from the above two subsets had significant survival benefit.

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